Matching-adjusted Indirect Comparison of the Efficacy of Loncastuximab Tesirine Versus Treatment in the Chemoimmunotherapy Era for Relapsed/Refractory Diffuse Large B-cell Lymphoma

Abstract

BackgroundLoncastuximab tesirine (Lonca) and chemoimmunotherapy (CIT) have been assessed in patients with relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL), but direct evidence from head-to-head randomized clinical trials is not available. Materials and MethodsMatching-adjusted indirect comparison (MAIC) was used to evaluate the efficacy of Lonca versus CIT-era treatment in R/R DLBCL. The analysis used individual patient data from the phase II LOTIS-2 trial of Lonca (NCT03589469) and pooled aggregated data from 2 extension studies of the CORAL trial for CIT. The LOTIS-2 trial included 145 patients who had relapsed or progressed following 2 or more multi-agent systemic treatment regimens; the CORAL extension studies included 203 patients who received 2 prior lines of therapy and 75 patients who relapsed after autologous hematopoietic cell transplantation. MAIC analyses were performed to adjust for cross-trial differences in inclusion/exclusion criteria and the distribution of observed baseline characteristics. Overall response rate (ORR) and overall survival (OS) were compared between the balanced trial populations. ResultsA total of 80 patients in LOTIS-2 were included in the analysis. After matching to the characteristics of 278 patients from the pooled CORAL extension studies, the ORR was significantly higher for Lonca compared with CIT-era treatment (53.4% vs. 40.3%, P < .05). Lonca was also associated with a significantly improved OS compared with CIT-era treatment (median OS 10.8 vs. 6.4 months; adjusted hazard ratio: 0.67 [95% CI: 0.48, 0.92], P < .05). ConclusionThis study indicates that Lonca was associated with significantly improved efficacy compared with CIT-era treatments for R/R DLBCL.